Penile prosthetic insert with a body having a channel and a method for implantation of a penile prosthetic

ABSTRACT

An implantable penile prosthetic insert for placement in a corpora cavernosum of a penis and capable of transitioning the penis between a flaccid and an erect state. A body of the insert is made from a bio-compatible material and extends between a proximal end and a distal end. The body includes an exterior surface defining a channel extending longitudinally along the body. The body is configured to transition between a first state corresponding to the flaccid state of the penis and a second state corresponding to the erect state of the penis. The channel is present in both the first and the second state. A method for implanting a penile prosthetic insert and a kit of parts are also disclosed.

BACKGROUND

An implanted penile prosthetic is effective in relieving erectiledysfunction in men.

A penile prosthetic typically includes a cylinder that is implanted ineach corpora cavernosum of the penis as well as a fluid reservoir andpump and valve mechanisms to move fluid from the reservoir to thecylinder to create an erection in the penis. Other penile prostheticsinclude a malleable cylinder without inflation fluid. The erectiledysfunction condition is typically a result of reduced or no bloodsupply to the tissue of the corpora cavernosum leading to thesponge-like tissue of the corpora losing its expanding capability. Thelack of blood supply to the corpora cavernosa may be caused by bothpsychological and physiological reasons and/or as a reaction tomedication.

Placement of a cylinder in the corpora cavernosum in a surgicalprocedure includes dilating the sponge-like tissue of the corporacavernosum with a Brooks® corporal dilator to form an implant spacesized to receive the cylinder.

The above-described penile prosthetics have proven effective inrelieving erectile dysfunction in men. However, improvements to penileprostheses would be welcomed by surgeons and patients alike.

SUMMARY

One aspect provides an implantable penile prosthetic insert that isconfigured to be placed in a corpora cavernosum of a penis and totransition the penis between a flaccid and an erect state. The insertincludes a body formed of a bio-compatible material and extends betweena proximal end and a distal end. The body includes an exterior surfacedefining a channel extending longitudinally along at least part of thebody. The body is configured to transition between a first statecorresponding to the flaccid state of the penis and a second statecorresponding to the erect state of the penis. The channel is moreresistant to deformation than a surrounding portion of the body suchthat the channel is present in both the first and the second state.

One aspect provides an implantable penile prosthetic insert that isconfigured to be placed in a corpora cavernosum of a penis and totransition the penis between a flaccid and an erect state. The insertincludes a body formed of a bio-compatible material and extends betweena proximal end and a distal end. The body includes an exterior surfacedefining a channel extending longitudinally along at least part of thebody. The body is configured to transition between a first statecorresponding to the flaccid state of the penis and a second statecorresponding to the erect state of the penis. The channel is present inboth the first and the second state.

One aspect provides a penile prosthetic system including an inflatablecylinder, a reservoir for storing of liquid and a pump connected betweenthe reservoir and the chamber via tubing. The inflatable cylinderincludes a body formed of a bio-compatible material extending between aproximal end and a distal end and having an exterior surface defining achannel extending longitudinally along at least part of the body. Thechannel is more resistant to deformation than a surrounding portion ofthe body such that the channel is present in both a deflated state andan inflated state of the body.

One aspect provides a method of implanting a penile prosthetic insert ina patient. The method includes making an incision in a patient andminimally dilating the corpora cavernosum to keep as much healthy tissueas possible in the corpora cavernosum. The method further includesintroducing an insert comprising a body formed of a bio-compatiblematerial and extending between a proximal end and a distal end andhaving an exterior surface defining a channel extending longitudinallyalong at least part of the body. The method further includes adjustingthe position of the insert in the corpora cavernosum.

One aspect provide a kit of parts including a packaging, an insertpositioning tool, a set of instructions for use and an implantablepenile prosthetic insert configured to be placed in a corpora cavernosumof a penis and to transition the penis between a flaccid and an erectstate. The body includes a bio-compatible material extending between aproximal end and a distal end and having an exterior surface defining achannel extending longitudinally along at least part of the body. Thechannel is present in both the first and the second state and sized toaccommodate at least a portion of the insert positioning tool.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated in and constitute apart of this specification. The drawings illustrate embodiments andtogether with the description serve to explain principles ofembodiments. Other embodiments and many of the intended advantages ofembodiments will be readily appreciated as they become better understoodby reference to the following detailed description. The elements of thedrawings are not necessarily to scale relative to each other. Likereference numerals designate corresponding similar parts.

FIG. 1 is a cross-sectional view of a penis P reclined against theabdomen in an orientation positioned for access by a surgeon.

FIG. 2A is a top view of one embodiment of a penile prosthetic insert.

FIG. 2B is a cross-sectional view of the insert of FIG. 2A taken alongthe line B-B in FIG. 2A.

FIG. 3A is a cross-sectional view of a penis P wherein some tissue ofthe corpora cavernosum has been dilated away while a portion ofvascularized tissue remains in the corpora cavernosum.

FIG. 3B is another cross-sectional view of a penis P showing an insertlocated in each of the corpora cavernosum, a channel in the insertaccommodating a remaining portion of vascularized tissue locatedadjacent a midline of the penis.

FIG. 4 is a top view of one embodiment of a penile prosthetic insertincluding a rear proximal tip and a front distal tip.

FIG. 5 is a sectional perspective view of one embodiment of a penileprosthetic insert including a channel with by a wall having a greaterthickness than a surrounding portion of a body of the insert.

FIGS. 6A-6C are cross-sectional views of different configurations ofembodiments of a channel in the body of a penile prosthetic insert.

FIG. 7A is a sectional perspective view of one embodiment of a penileprosthetic insert including a channel provided with a reinforcing layer.

FIG. 7B is a cross-sectional view of the insert of FIG. 7A.

FIG. 7C is a schematic perspective view of one embodiment of thereinforcing layer of FIG. 7A-7B.

FIG. 8 is a sectional perspective view of one embodiment of a penileprosthetic insert including a channel coated with a tissue ingrowthpromoting material.

FIG. 9 is a schematic perspective view of one embodiment of an insertincluding a malleable cylinder.

FIG. 10 is a partly cross-sectional side view of one embodiment of apenile prosthetic insert including an inflatable chamber having achannel.

FIG. 11A is a schematic side view of one embodiment of a penileprosthetic insert and an insert positioning tool engaged with the insertand partly accommodated in a channel in the insert.

FIG. 11B is a sectional top view of a distal end portion of the insertof FIG. 11A.

FIG. 12 is a perspective view of one embodiment of a penile prostheticsystem.

FIG. 13 is a top view of one embodiment of a kit of parts including apenile prosthetic insert having a channel, an insert positioning tooland a set of instructions for use.

FIG. 14A is a perspective view of one embodiment of a dilation toolhaving a dilation portion including a groove.

FIG. 14B is a cross-sectional view of the dilation portion of thedilation tool of FIG. 14A.

FIG. 14C is a perspective sectional view of a dilation portion of adilation tool according to one embodiment.

FIG. 14D is a side view of the embodiment of the dilation portionillustrated in FIG. 14C.

FIG. 14E is a cross-sectional view of one embodiment of a dilationportion including a plurality of grooves.

FIG. 15 is a top view of one embodiment of a combined insert positioningtool and dilation tool.

FIGS. 16-18 are block diagrams illustrating embodiments of a method ofimplanting a penile prosthetic insert in a patient.

DETAILED DESCRIPTION

In the following Detailed Description, reference is made to theaccompanying drawings, which form a part hereof, and in which is shownby way of illustration specific embodiments in which the invention maybe practiced. In this regard, directional terminology, such as “top,”“bottom,” “front,” “back,” “leading,” “trailing,” etc., is used withreference to the orientation of the Figure(s) being described. Becausecomponents of embodiments can be positioned in a number of differentorientations, the directional terminology is used for purposes ofillustration and is in no way limiting unless otherwise specified. It isto be understood that other embodiments may be utilized and structuralor logical changes may be made without departing from the scope of thepresent invention. The following detailed description, therefore, is notto be taken in a limiting sense, and the scope of the present inventionis defined by the attached claims.

It is to be understood that the features of the various exemplaryembodiments described herein may be combined with each other, unlessspecifically noted otherwise.

The term “proximal” in this application means that part that is situatednext to or near the point of attachment or origin or a central point;for example, as located toward a center of the human body. The prostateis proximal relative to skin of the patient.

The term “distal” in this application means that part that is situatedaway from the point of attachment or origin or the central point; forexample, as located away from the center of the human body. The glanspenis is distal relative to the crus penis of the patient.

End means endmost. A distal end is the furthest endmost location of adistal portion of a thing being described, whereas a proximal end is thenearest endmost location of a proximal portion of the thing beingdescribed. The portion next to or adjacent to an end is an end portion.For example, a twelve inch ruler has a center point at six inches, afirst end at zero inches and a second, opposite end at twelve inches, anend portion adjacent to the first end and another end portion adjacentto the second end.

Embodiments provide an implantable penile prosthetic insert configuredto be placed in a corpora cavernosum of a penis. The insert includes abody formed of a bio-compatible material extending between a proximalend and a distal end and having an exterior surface defining a channelextending longitudinally along at least part of the body. The body isconfigured to transition between a first state corresponding to aflaccid state of the penis and a second state corresponding to the erectstate of the penis. The channel is present in both the first and thesecond state. Providing a channel in the exterior surface of the body isuseful to provide room or space in the corpora cavernosum for tissuethat desirably remains vascularized or revascularizes followingimplantation of the insert. Embodiments provide an implantable penileprosthetic insert wherein the channel is more resistant to deformationthan a surrounding portion of the body.

Embodiments provide a penile prosthetic system including an inflatablecylinder, a reservoir for storing of liquid and a pump connected betweenthe reservoir and the cylinder via tubing.

Embodiments provide a method of implanting a penile prosthetic in apatient providing for less dilation of healthy penile tissue and therebyincrease the quality of the erection.

Embodiments provide a method of implanting a penile prosthetic in apatient wherein the channel is defined by a reinforcing wall having agreater rigidity than a surrounding portion of the body.

Embodiments provide a kit of parts including a packaging, an insertpositioning tool, a set of instructions for use and an implantablepenile prosthetic insert configured to be placed in a corpora cavernosumof a penis and to transition the penis between a flaccid and an erectstate.

FIG. 1 is a cross-sectional view of a penis P. The penis P has been“flipped back” to recline against the abdomen, which is an orientationemployed by surgeons for access to the proximal and distal reaches ofthe penis P. The surgeon gains access to the corpora cavernosa thoughsmall incisions, and with this in mind, the cross-sectional view of FIG.1 is not the view observed by the surgeon. In the view of FIG. 1 thepenis P of the patient is reclined against the torso such that theurethra U, surrounded by corpus spongiosum tissue, is oriented upward.

In preparation for the implantation of the penile prosthesis, the groinarea of the patient is shaved, cleaned and suitably prepped with asurgical solution prior to draping with a sterile drape as directed bythe healthcare provider's procedures. A retraction device, such as aretractor sold under the trademark Lone Star and available from LoneStar Medical Products of Stafford, Tex., is placed around the penis P. Acatheter is inserted into the urethra U from the distal end of the penisP into the bladder. Thereafter, the surgeon forms an incision to accessthe corpora cavernosa C1 and C2 of the penis.

Suitable examples of incisions include either an infrapubic incision ora transverse scrotal incision. The infrapubic incision is initiatedbetween the umbilicus and the penis (i.e., above the penis), whereas thetransverse scrotal incision is made across an upper portion of thepatient's scrotum.

In the transverse scrotal approach the surgeon forms a 2-3 cm transverseincision through the subcutaneous tissue of the median raphe of theupper scrotum and dissects down through the Darto's fascia Df and Buck'sfascia Bf to expose the tunicae albuginea TA of the penis P. Thereafter,each corpora cavernosum C1 and C2 is exposed in a corporotomy where asmall (approximately 1.5 cm) incision is formed to allow the surgeon toaccess to the corpora cavernosa C1 and C2.

In a typical approach, one or both of the corpora cavernosum C1, C2 isdilated with an appropriate dilation tool to form a recess in the penisP that is sized to receive an insert, e.g. a cylinder. A dilation toolincluding length indicia is inserted into the dilated corpora cavernosumC1, C2 to measure the length of the corpora prior to selecting anappropriately sized insert. The dilation tool is removed from the penisP.

In some cases, patients suffering from erectile dysfunction have some,or even a majority of healthy tissue left in the corpora cavernosum butare unable to get an erection due to other reasons. It is beneficial tothe patient and his sexual partner if as little as possible of healthytissue of the corpora cavernosum is dilated away prior to placement ofan implant, for at least the reason that the healthy tissue that remainswill allow the penis to remain warm to the touch. Having some remainingvascularized tissue inside the corpora cavernosum, even with a penileprosthetic implanted in the corpora cavernosum, helps provide for abetter (harder, bigger) as well as a more naturally feeling erectionbecause better or more flow of warm blood provides warming of thesurrounding penile tissue. Particularly advantageous is improved flow ofwarm blood to the tissue of, or adjacent to, the penis glans.

FIG. 2A is a top-view of one embodiment of an implantable penileprosthetic insert (PPI) 20 configured to be placed in a corporacavernosum C1, C2 of a penis P. In one embodiment, the PPI 20 includes abody 22 formed of a bio-compatible material and extends between aproximal end 24 and a distal end 26. In one embodiment, the body 22includes an exterior surface 28 that defines a channel 30 extendinglongitudinally along at least part of the body 22. In one embodiment,the body 22 is configured to transition between a first statecorresponding to a flaccid state of the penis and a second statecorresponding to an erect state of the penis. In the erect state theinsert has a column strength that is selected to be sufficient to permitpenetration associated with intercourse. In one embodiment, the channel30 is more resistant to deformation than a surrounding portion of thebody 22. In one embodiment, for example, the channel 30 is moreresistant to deformation such that the channel 30 is present in both thefirst and in the second state. Embodiments achieving a higher resistanceto deformation of the channel in relation to a surrounding portion ofthe body 22 include but are not limited to differentiating materials,differentiating thicknesses of materials, differentiating elasticitymodules and incorporating one or more layers of other materials andstructure between the channel 30 and the surrounding portion of the body22. In this disclosure, the wording “present” in relation to the channel30 in both states means that the channel does not go away even if asurrounding portion of the body 22 is deformed. In one embodiment, across-section of the channel 30 stays the same in both states. In oneembodiment, a cross-section of the channel may change when the body 22transitions between the first and the second states, but the channeldoes not lose its functionality. FIG. 2B is a cross-sectional view ofthe body 22 including the channel 30 of FIG. 2A.

In one embodiment, the channel 30 in the body 22 of the PPI 20 providesroom or a space for healthy penile tissue to locate therein. The channel30 provides an opportunity for the surgeon to minimally dilate thecorpora cavernosum, thereby providing room for some vascularized tissueto remain in the corpora to transport blood while simultaneouslyproviding implantation of a PPI 20. In one embodiment, the channel issized to allow penile tissue to dwell in the channel with sufficientvascularization of the dwelling penile tissue when the PPI 20 isimplanted in the penis.

FIG. 3A is a cross-sectional view of a penis P similar to FIG. 1 inwhich some, but not all of the spongiosis tissue of the corporacavernosa C1, C2, has been dilated away thereby leaving a recess forplacement of a penile prosthetic, but also leaving some healthyvascularized tissue VT in the corpora C1, C2 to transport blood.

FIG. 3B is another cross-sectional view of a penis P similar to FIGS. 1and 3A and showing a body 22 of a PPI 20 located in each corporacavernosum C1, C2. A longitudinally extending channel 30 is defined inthe exterior surface 28 of the body 22 and provides room or space formaintaining some of the vascularized tissue VT in the corpora even afterimplantation of the PPI 20.

FIG. 4 is a top view showing one embodiment, wherein the PPI 20 includesa rear proximal tip 32 attached to a proximal end portion of the body22. In one embodiment the PPI 20 includes a front distal tip 34 attachedto a distal end portion of the body 22. In one embodiment, the PPI 20includes an inflatable chamber configured to be inflated by filling theinflatable chamber with inflation fluid to create an erection in thepenis. In one embodiment, the rear proximal tip 32 includes a conduit 36one end of which is in fluid communication with the inflation chamberand another end of which conduit is attachable to a supply of inflationfluid. Among other things, the rear proximal tip 32 is useful forstabilizing the implanted PPI 20 in the crus of the penis. Among otherthings, the front distal tip 34 is useful for improved filling of thedistal end of the corpora cavernosum.

In one embodiment, the channel 30 includes a reinforced sidewall 38characterized by a greater rigidity of the body 22 along the channel 30.FIG. 5 is a perspective end view of one embodiment of the body 22wherein the reinforcement of the sidewall 38 includes an increasedthickness T of the wall 38 compared to a thickness t of a surroundingportion of the body 22. The increased thickness T of the wall 38 can beobtained through applying subsequent layers of the material used for thebody 22 to build up the wall thickness.

In one embodiment, the channel 30 includes two mutually facing walls 40a, 40 b. FIGS. 6A-6C are cross-sectional views of differentconfigurations of a body 22 including a channel 30 and also includingtwo mutually facing sidewalls 40 a, 40 b. FIG. 6A shows one embodimentof a rectangular shaped cross-section of the channel 30 in which themutually facing sidewalls 40 a, 40 b are vertical. FIG. 6B shows oneembodiment of a V-shaped cross-section of the channel 30 in which themutually facing sidewalls 40 a, 40 b are at an incline. FIG. 6C showsone embodiment of a channel 30 having inclined mutually facing sidewalls40 a, 40 b and a third wall 40 c. FIG. 6C also shows one embodimentincluding a second channel 42. More than one channel, i.e. a pluralityof channels 30, 42 can be incorporated in the body 22 to further ensureincreased vascularization. Other cross-sectional configurations of thechannels 30, 42 in the body 22 of the PPI 20 are acceptable. In someembodiments, a cross-sectional area of the channel 30, 42 is 5-50% of atotal cross-sectional area of the insert. The dimensions and shape ofthe channel 30, 42 can be configured to help providing for adifferentiation between the channel 30, 42 and the surrounding portionof the body 22 such that the channel 30, 42 is more resistant todeformation than the body.

FIG. 7A is a perspective end view of one embodiment wherein the body 22includes a reinforcing layer 44 extending along the channel 30. In oneembodiment, the reinforcing layer 44 is integrally formed with a wall 40d of the channel 30. In one embodiment, the reinforcing layer 44 isincorporated within the wall 40 d as shown in the cross-sectional viewof the body 22 in FIG. 7B. In one embodiment, the reinforcing layer isprovided as an individual layer attached to the exterior surface 28 ofthe body 22 by bonding or welding. FIG. 7C is a schematic view of oneembodiment of the reinforcing layer 44 including a mesh structure 46.The mesh structure 46 can include polymeric and/or metallic materials.

FIG. 8 is a perspective end view of one embodiment wherein the channel30 includes a tissue facing surface 48 provided with a tissue ingrowthpromoting material 50. Providing a tissue ingrowth promoting material inthe channel 30 provides a possibility for increasing the level ofvascularized tissue in the channel 30 of the PPI 20 and in the corporacavernosum by natural ingrowth of tissue, thereby leading to even betterflow of blood but also aiding in retaining the body 22 of the PPI 20stabile in the corpora cavernosum. Suitable tissue ingrowth promotingmaterials include PGA-Polyglycolide, PLLA—Poly(L-lactic acid),PLGA—Poly(1-lactide-co-glycolide), PLGA-collagen, PEU—Poly(esterurethane) and Collagen.

The body 22 is configured to transition between a first statecorresponding to a flaccid state of the penis and a second statecorresponding to an erect state of the penis. To achieve thistransition, in one embodiment, the PPI 20 includes a malleable shaft.

FIG. 9 is a perspective view of one embodiment wherein the body 22 ofthe PPI 20 includes a malleable cylinder including a silicone elastomershaft 52 and a silver wire coil 54 configured to be placed around asilver wire core 56. In one embodiment, a portion of the core and coilis wrapped in a polymer 58 such as urethane and at least one otherportion is wrapped in a polymer such as a polyester or a polyethyleneterephthalate. In one embodiment, both portions are over-molded with asilicone rubber to form the body 22. In one embodiment, a hydrophiliccoating can be applied to the exterior surface of the body 22. In oneembodiment, a channel 30 for accommodating vascularized tissue isprovided in an exterior surface 28 of the body 22. In one embodiment,the hydrophilic coating can also be in the channel 30. The silver wirecoil and core in the cylinder enables the PPI 20 to transition betweenan erect position (second state) for sexual activity and a loweredflaccid position (first state) for concealment under clothing.

In one embodiment, the transition of the body 22 between the first andthe second state is done by inflating/deflating an inflatable chamber ofthe body 22 with an inflation fluid. The inflatable chamber isconfigured to be in fluid communication with a fluid reservoir throughtubing and a pumping means. The pumping means is configured to beactivatable to pump inflation fluid from the reservoir to the inflatablechamber of the body 22 in order for the body 22 to transition from thefirst flaccid state to the second state. The pumping means can include adeflation valve configured for deflating the inflatable chamber andtransition the body 22 back into the first state.

FIG. 10 is a side view of one embodiment, wherein the body 22 of theinsert 20 includes an inflatable chamber 35. In one embodiment, theinsert 20 includes a rear proximal tip 32 attached to a proximal endportion of the body 22. In one embodiment, tubing 36 extending from therear proximal tip 32 and being in fluid communication with an inflatableportion of the body 22, extends in a portion of the channel 30. In someembodiments, the channel 30 extends further along the longitudinalextent of the body 22, such as proximally beyond the interface with therear proximal tip and distally beyond the interface with the frontdistal tip 34. In the side view of FIG. 10, the channel 30 is shown inphantom line. Configuring the tubing 36 in the channel 30 provides forthe penile prosthetic to take up less space in the corpora cavernosumduring implantation. This is advantageous in that the inflatable chamberoften is somewhat inflated during implantation of the insert. Thisfacilitates an easier insertion of the insert into the corpora for thesurgeon and also means that less potentially healthy tissue is dilatedaway from the corpora when implanting the insert.

FIG. 11A is a side view showing one embodiment wherein a distal endportion 60 of the body 22 includes an engagement feature 62 configuredfor releasable engagement with an insert positioning tool 64. In oneembodiment, the engagement feature 62 includes a ledge 66 overlaying andcovering a portion of the channel 30 at the distal end portion 60 of thebody 22. FIG. 11B is a top view of the distal end portion 60 of the body22 indicating the position of the ledge 66. Configuring the engagementfeature 62 as ledge 66 allows for the insert positioning tool 64 to beretracted after positioning of the body 22 in the corpora cavernosumwith reduced or no probability of unintentionally pulling the body 22 ofthe PPI 20 back out through the incision.

An insert positioning tool 64 is shown in FIG. 11A. In one embodiment,the tool 64 includes an elongated stem 68 connected to a handle 70through an intermediate section. In one embodiment, the intermediatesection 72 is S-shaped. In one embodiment, the tool 64 includes astraight stem connected to a handle without an intermediate section. Asschematically shown in FIG. 11A, the elongated stem 68 is advantageouslysized to be positionable in the channel 30 of the body 22 of the PPI 20.When the PPI 20 is to be positioned in the corpora cavernosum the stem68 locates in the channel 30 and is in engagement with ledge 66 therebymaking it possible to move the body 22 distally (forward) towards thepenis glans. A distal end portion 74 of the insert positioning tool 64is configured for engagement with the engagement feature 62 of the body22. The engagement feature 62 is configured to allow easy engagement anddisengagement with the insert positioning tool 64 such that the tool 64can be easily released from the engagement with the insert 20. As thestem 68 of the insert positioning tool 64 is sized to be accommodatedthe channel 30, the insert positioning tool 64 is easily retractable“through” the channel 30 and the incision with less risk of damaginghealthy tissue. Also, using the insert positioning tool 64 to positionand locate the insert 20 in the corpora cavernosum obviates the need forusing a needle (sometimes called a “Keith” needle) for the positioningof the insert 20. In a typical procedure, an insert of appropriatelyselected size length is secured to a suture, and the suture is securedto a needle that is delivered through the dilated corpora cavernosum andout the glans penis where the suture is employed to tow the insert intoplace within the dilated corpora cavernosum Using the insert positioningtool 64 instead of a needle and a tow suture attached to the inserthelps provide for faster healing times to the benefit of the patient.The channel 30 in the exterior surface 28 of the body 22 helps providefor accommodation of the insert positioning tool 64 and thereby foreasier insertion and removal of the tool and insert.

In one aspect, the disclosure relates to a penile prosthetic system.FIG. 12 is a perspective view of one embodiment of a penile prostheticsystem 120 of the application. The system includes an inflatablecylinder 121, a reservoir 125 for storing of liquid and a pump 127. Thepump 127 is connected between the reservoir 125 and the cylinder 121 viatubing 136. The pump is configured to move liquid from the reservoir 125to the cylinder 121 upon activation of the pump by the user. Thecylinder 121 includes a body 122 formed of a bio-compatible materialextending between a proximal end 124 and a distal end 126 and having anexterior surface 128. A channel 130 is defined in the exterior surface128 and extends longitudinally along at least part of the body 122. Thechannel 130 is more resistant to deformation than a surrounding portionof the body 122. The channel 130 provides for accommodation of somehealthy tissue in the corpora cavernosum along the implanted cylinder121 and provides similar advantages as described above for the channel30 in the penile prosthetic insert 20.

In one aspect, the disclosure relates to a kit of parts. FIG. 13 is atop view of a kit of parts 200 of the application including a packaging202 containing a penile prosthetic insert 20, an insert positioning tool64 and a set of instructions for use 204. The insert 20 is configured tobe placed in a corpora cavernosum of a penis and to transition the penisbetween a flaccid and an erect state. The insert 20 includes a bodyformed of a bio-compatible material extending between a proximal end anda distal end and having an exterior surface defining a channel 30extending longitudinally along at least part of the body. The body 22 isconfigured to transition between a first state corresponding to theflaccid state of the penis and a second state corresponding to the erectstate of the penis. The channel 30 is present in both the first and thesecond state. In one embodiment, the channel is sized to accommodate atleast a portion of the insert positioning tool 64. In one embodiment,the kit of parts 200 includes an insert 20 having a body 22 including aninflatable cylinder. In one embodiment, the kit of parts 200 includes aninsert 20 having a body 22 including a malleable cylinder.

In one embodiment, the kit of parts 200 includes a grooved dilator 210for dilating the corpora cavernosum.

FIG. 14A shows one embodiment, wherein the grooved dilator 210 includesa handle portion 212, and a stem portion 214 connected between thehandle portion 212 and a distal end portion 217. In one embodiment, thehandle portion 212 and the stem portion 214 are connected via anintermediate section 216. In one embodiment, the intermediate section216 is S-shaped. A distal end portion 217 of the grooved dilator 210includes a dilation portion 218 of larger second diameter D2 than afirst diameter D1 of the stem portion 214.

In one embodiment, the dilation portion 218 includes a groove 219 orrecess in an exterior surface of the dilation portion 218 that isprovided to ensure that some of the tissue of the corpora is notdilated, or remains un-dilated when forming a space in the corporacavernosa for placement of the implant.

The dilation portion 218 of the grooved dilator 210 is configured toleave at least one section or segment of tissue in the corporaundisturbed and un-dilated. The undisturbed tissue remains vascularized(or re-vascularizes) to beneficially warm the penis and aid in effectingan erection. Without being bound to this theory, vascularization of thesection of tissue that is left undisturbed is thought to play a role inassisting in achieving an erection and in warming an erect penis.Partners have expressed a desire to have the tip portion of the peniswarm after an erection is achieved.

In one embodiment, groove 219 extends along the entire length of thedilation portion 218 (FIG. 14A). In one embodiment, the handle portion212 includes indicia 213 indicating a corresponding position of thegroove 219 in an exterior surface of the dilation portion 218.Alternatively, the indicia 213 can be provided on the stem portion 214or on both the handle and stem portions. In one embodiment, groove 219is formed to have a constant groove depth. FIGS. 14C-14D show aperspective view and a side view respectively of one embodiment of thedilation portion 218 (handle 212 and stem 214 of dilator 210 not shown)wherein groove 219 is formed to be deeper along a proximal portion 221of the dilation portion 218 and shallower along a distal portion 223 ofthe dilation portion 218. In one embodiment, the exterior surface of thedilation portion 218 defines a plurality of grooves 219 (FIG. 14E). Inone embodiment illustrated in FIG. 14B, the groove 219 has across-sectional profile corresponding to the channel 30 (such as e.g.that of FIG. 6B) in the exterior surface of the body of the insert.Thereby, the grooved dilator 210 can advantageously be used to dilatethe corpora cavernosum prior to the introduction of the PPI 20 having achannel 30 of corresponding profile. In one embodiment, the groove 219or recess of the grooved dilator 210 is sized to have a cross-sectionalprofile area that is 5-50% larger than the cross-sectional profile areaof the channel 30 in the body 22 of the PPI 20.

In one embodiment, the insert positioning tool 64 and the grooveddilator 210 of the kit of parts 200 are integrated into a single device222. FIG. 15 is a top view of the device 222. In one embodiment, thedevice 222 includes a handle portion 224 provided between a positioningportion 226 and a dilating portion 228. In one embodiment, thepositioning portion includes a stem 230 and a distal end portion 232configured to engage with an engagement feature of a PPI 20. In oneembodiment, the dilating portion 228 includes a stem 234 and a dilationportion 236 including a groove 238. In one embodiment, the groove 238corresponds to a channel 30 in a PPO 20 and can advantageously be usedto dilate the corpora cavernosum prior to the introduction of the PPI 20that is then introduced by using the positioning portion 226 of thedevice 222 to introduce and correctly locate the insert 20.

The insert includes a body formed of a bio-compatible material. Suitablebio-compatible materials for the body of the insert include silicones,polymers such as urethanes, blends of polymers with urethane, copolymersof urethane and ePTFE.

In one aspect, the disclosure relates to a method of implanting a penileprosthetic in a patient. FIG. 16 is a block diagram showing oneembodiment of the method 300. After having prepared the patient for thesurgical procedure in a manner described above, the surgeon at 302 makesan incision in the patient. At 304, the surgeon minimally dilates thecorpora cavernosum, thereby making sure to keep (or maintain) as muchhealthy tissue as possible in the corpora cavernosum. At 306, thesurgeon introduces an insert 20 including a body 22 formed of abio-compatible material extending between a proximal end 24 and a distalend 26 and having an exterior surface 28 defining a channel 30 extendinglongitudinally along at least a part of the body 22. In one embodiment,the surgeon at 308 adjusts the position of the insert 20 in the corporacavernosum such that the insert 20 is optimally located. The channel 30in the exterior surface 28 of the insert 20 provides room or space forthe non-dilated remaining tissue inside the corpora cavernosum to dwellin and thereby maintain a supply of warm blood through the healthytissue, in turn increasing the quality of the erection. At least duringintroduction of the insert 20 into the corpora cavernosum, the channel30 in the exterior surface 28 of the body 22 also provides a relief area(or zone) for the healthy tissue that has not been dilated away. Thechannel 30 in the body 22 of the insert 20 is useful in the method ofimplanting the penile prosthetic also for the reason that it providesfor less of the healthy tissue to be removed thereby saving time used todilate the corpora. The step of minimally dilating the corporacavernosum can advantageously be carried out using a grooved dilatorhaving a groove with a cross-sectional profile corresponding to thecross-sectional profile of the channel of the body of the insert to beimplanted. Thereby, the grooved dilator prepares the way for thecorresponding profile of the body of the insert.

FIG. 17 is a block diagram showing one embodiment 310, wherein theadjusting the position of the insert in the corpora cavernosum 308includes at 312 placing an insert positioning tool 64 in and along thechannel 30 in the exterior surface 28 of the body 22 of the insert 20.In one embodiment, the adjusting of the position includes engaging adistal end of the insert positioning tool 64 with an engagement feature62 provided on a distal end portion of the body 22. The adjusting of theposition includes moving the insert positioning tool 64 in a distaldirection. Thereby the insert 20 is pushed forward into the corporacavernosum such that the distal end portion of the body 22 locates at adistal end of the corpora closest to the penis glans. In one embodiment,the adjusting of the position includes releasing the insert positioningtool 64 from engagement with the engagement feature 62 and withdrawingthe insert positioning tool 64 from the corpora cavernosum along thechannel 30 and out through the incision in the patient. Withdrawal ofthe tool 64 via the channel 30 in the insert 20 provides a reduced oreliminated probability of interfering with healthy tissue duringretraction of the positioning tool. As the insert positioning tool 64can further be releasably engaged with the insert 20, any chance ofunintentionally withdrawing the implanted insert 20 back out through theincision during removal of the tool 64 is also greatly reduced oreliminated.

FIG. 18 is a block diagram showing one embodiment 314, wherein themethod includes leaving a majority of the healthy tissue in a portion ofthe corpora cavernosum adjacent a midline of the penis (see also FIG.3A).

In another embodiment 316, the method includes aligning the channel ofthe insert in the corpora cavernosum such that the channel faces towardsand is configured to engage the healthy tissue adjacent the midline ofthe penis.

Leaving a majority of the healthy tissue in the corpora adjacent amidline of the penis and aligning the channel of the insert to facetowards that tissue ensures that the patient does not experience anundesirable unevenness of the surface of the penis during an erection.Also, keeping the healthy tissue adjacent the midline is believed toprovide the best conditions for improved vascular flow and therebysupply of warm blood towards the penis glans. In other embodiments, themajority of healthy tissue could include portions of tissue along a partor an entire periphery of the corpora cavernosum. In one embodiment, aPPI 20 could be located in a corpora cavernosum such that it isencircled by healthy tissue. Depending on individual patient needs,different tissue areas or zones may be particularly desirable to keepfor achieving an optimal erection.

Embodiments provide an improved penile prosthetic insert and a methodfor implantation of the insert for treating erectile dysfunction. Thepenile prosthetic insert described in this disclosure helps provide fora larger portion of healthy vascularized tissue to remain in the corporacavernosum of a penis thereby leading to increased quality of theerection. Also, the channel in the exterior surface of the body ofinsert helps provide for accommodating an insert positioning tool duringincorporation and adjusting of the position of the insert in the penisand retracting the tool with little or no probability of unintentionallywithdrawing the insert. The insert positioning tool obviates use of aneedle and a tow suture attached to the insert for positioning theinsert in the corpora cavernosum and helps provide for reduced trauma topenile tissue and thereby to faster healing times to the benefit of thepatient.

Although specific embodiments have been illustrated and described, itwill be appreciated by those of ordinary skill in the art that a varietyof alternate and equivalent implementations may be substituted for thespecific embodiments shown and described without departing from thescope of the present invention. This application is intended to coverany adaptations or variations of the kind of medical devices describedabove. Therefore, it is intended that this invention be limited only bythe claims and their equivalents.

1. An implantable penile prosthetic insert configured to be placed in acorpora cavernosum of a penis and to transition the penis between aflaccid and an erect state, the implantable penile prosthetic insertcomprising: a body formed of a bio-compatible material extending betweena proximal end and a distal end and having an exterior surface defininga channel extending longitudinally along at least part of the body;wherein the body is configured to transition between a first statecorresponding to the flaccid state of the penis and a second statecorresponding to the erect state of the penis, and wherein the channelis more resistant to deformation than a surrounding portion of the bodysuch that the channel is present in both the first and the second state.2. The penile prosthetic insert of claim 1, wherein the insert comprisesan inflatable chamber.
 3. The penile prosthetic insert of claim 1,wherein the insert comprises a malleable shaft.
 4. The penile prostheticinsert of claim 1, wherein the channel comprises a reinforced sidewallcharacterized by a greater rigidity of the body along the channel. 5.The penile prosthetic insert of claim 4, wherein the reinforcement ofthe sidewall comprises an increased thickness of the wall.
 6. The penileprosthetic insert of claim 1, wherein the channel comprises two mutuallyfacing walls.
 7. The penile prosthetic insert of claim 1, wherein thebody includes a reinforcing layer extending along the channel.
 8. Thepenile prosthetic insert of claim 7, wherein the reinforcing layer isintegrally formed with a wall of the channel.
 9. The penile prostheticinsert of claim 7, wherein the reinforcing layer comprises a meshstructure.
 10. The penile prosthetic insert of claim 1, wherein thechannel comprises a tissue facing surface including tissue ingrowthpromoting material.
 11. The penile prosthetic insert of claim 1, furthercomprising a front distal tip attached to a distal end portion of thebody.
 12. The penile prosthetic insert of claim 1, further comprising arear proximal tip attached to a proximal end portion of the body. 13.The penile prosthetic insert of claim 12, wherein tubing extending fromthe rear proximal tip, and in fluid communication with an inflatableportion of the body, extends in a portion of the channel.
 14. The penileprosthetic insert of claim 1, wherein a distal end portion of the bodycomprises an engagement feature configured for releasable engagementwith an insert positioning tool.
 15. The penile prosthetic insert ofclaim 1, wherein the channel is sized to allow penile tissue to dwell inthe channel with sufficient vascularization of the dwelling peniletissue when the penile prosthetic insert is implanted in a penis. 16.The penile prosthetic insert of claim 1, wherein the body includes aplurality of channels.
 17. The penile prosthetic insert of claim 1,wherein a cross-section of the channel is rectangular.
 18. The penileprosthetic insert of claim 1, wherein a cross-section of the channel isV-shaped.
 19. A penile prosthetic system comprising: an inflatablecylinder; a reservoir for storing of liquid; a pump connected betweenthe reservoir and the cylinder via tubing and configured to move liquidfrom the reservoir to the cylinder upon activation of the pump by theuser; wherein the cylinder comprises: a body formed of a bio-compatiblematerial extending between a proximal end and a distal end and having anexterior surface defining a channel extending longitudinally along atleast part of the body, and wherein the channel is more resistant todeformation than a surrounding portion of the body.
 20. (canceled) 21.(canceled)
 22. (canceled)
 23. (canceled)
 24. (canceled)
 25. Animplantable penile prosthetic insert configured to be placed in acorpora cavernosum of a penis and to transition the penis between aflaccid and an erect state, the implantable penile prosthetic insertcomprising: a body formed of a bio-compatible material extending betweena proximal end and a distal end and having an exterior surface defininga channel extending longitudinally along at least part of the body;wherein the body is configured to transition between a first statecorresponding to the flaccid state of the penis and a second statecorresponding to the erect state of the penis; and wherein the channelis present in both the first and the second state.
 26. A kit of partscomprising: a packaging; an insert positioning tool; a set ofinstructions for use, and an implantable penile prosthetic insertconfigured to be placed in a corpora cavernosum of a penis and totransition the penis between a flaccid and an erect state, theimplantable penile prosthetic insert comprising: a body formed of abio-compatible material extending between a proximal end and a distalend and having an exterior surface defining a channel extendinglongitudinally along at least part of the body; wherein the body isconfigured to transition between a first state corresponding to theflaccid state of the penis and a second state corresponding to the erectstate of the penis; and wherein the channel is present in both the firstand the second state and sized to accommodate at least a portion of theinsert positioning tool.
 27. The kit of parts of claim 26, wherein thebody of the implantable penile prosthetic insert comprises an inflatablecylinder.
 28. The kit of parts of claim 27, further comprising areservoir for storing of liquid and a pump connected between thereservoir and the cylinder via tubing and configured to move liquid fromthe reservoir to the cylinder upon activation of the pump by the user.29. The kit of parts of claim 26, further comprising a dilator having ahandle portion, a stem portion, an intermediate portion connecting thehandle portion and the stem portion, wherein a distal end portion of thestem portion has a larger diameter than the stem portion and includes anexterior surface defining a groove.
 30. The kit of parts of claim 29,wherein a profile of the groove corresponds to the channel in the bodyof the insert.